KarXT for Bipolar Disorder

Recruiting at 63 trial locations

Overseen By BMS Study Connect www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Psychotropics

Disqualifiers: BP-II, Major depression, Substance use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

274 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking all psychotropic medications (drugs that affect mood, perception, or behavior) at least 14 days before starting the trial medication.

What makes the drug KarXT unique for treating bipolar disorder?

KarXT is unique because it combines two components, xanomeline and trospium, which work together to target specific brain receptors differently than traditional treatments like lithium or valproate. This novel mechanism may offer new benefits for managing bipolar disorder symptoms. ^{1 2 3 4 5}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with Bipolar-I disorder experiencing a severe manic or mixed episode, requiring hospitalization. They must have specific scores on mania and global impression scales, no other major psychiatric disorders in the past year (except mild anxiety), no recent substance abuse, and not be at risk of suicide.

Inclusion Criteria

Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline

Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline

I have been diagnosed with Bipolar-I disorder by a psychiatrist.

Exclusion Criteria

Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders

Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test

Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive KarXT or placebo during a 3-week inpatient period to evaluate efficacy in treating manic episodes

3 weeks

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• KarXT

Trial Overview The study tests KarXT against a placebo over three weeks to see if it's better at treating mania symptoms in Bipolar-I patients. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug versus placebo.

Participant Groups

Group I: KarXT Experimental Treatment 1 Intervention

Flexible dosing

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Neuroprotective and antioxidant effects of curcumin in a ketamine-induced model of mania in rats. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Na+, K+-ATPase α Isoforms and Endogenous Cardiac Steroids in Prefrontal Cortex of Bipolar Patients and Controls. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of behavioral and neurochemical changes induced by ketamine in rats: implications as an animal model of mania. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The Bipolar Illness Onset study: research protocol for the BIO cohort study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

The Neurobiology of Bipolar Disorder. [2021]